COE Program Requirements:

The primary requirement for applying to COE is that the applicant surgeon should be a member of OSSI for at least a period of 3 years at the time of application. The application facility should have a dedicated bariatric / metabolic surgery department functioning for at least a period of 12 months at the time of application. The department should also have entered their three years surgical data in to the registry by the time of inspection.

Surgical Experience:

The applicant surgeon / facility has performed at least 50 qualifying bariatric surgery procedures including restrictive, malabsorptive and revisional procedures in the preceding 12 months. Also, each applicant surgeon has performed at least 200 qualifying bariatric surgery procedures in their lifetime. All these procedures should have been entered in the OSSI Registry. Application failing to comply with the above clause will not be considered for COE.

Each applicant facility and surgeon meets surgical outcomes benchmarks for mortalities, complications, readmissions and reoperations.

Qualifying Procedures:

The following procedures, whether open, laparoscopic, and robotic qualify:

• Adjustable Gastric band
• Banded or Non-banded Roux-En-Y Gastric Bypass
• One anastomosis / Mini Gastric Bypass
• Sleeve gastrectomy
• Biliopancreatic diversion with Duodenal switch
• Ileal Interposition
• Other published novel bariatric procedures

The following procedures, whether open, laparoscopic, robotic also qualify when performed on bariatric surgery patients:

• Conversion to a primary procedure listed above
• Removal / Replacement of a slipped or eroded gastric band
• Altering the length of the bypass limb (Roux limb / Common channel)
• Gastric pouch revision
• Reversal of gastric bypass, vertical banded gastroplasty, biliopancreatic diversion and duodenal switch procedures
• Re-Sleeve for weight gain or sleeve dilation

Outcomes Benchmarks:

Applicant facilities and surgeons are required to meet the following outcomes benchmarks.

Mortalities:

Overall mortality for all bariatric surgery procedures performed at the applicant facility: 0.2%-0.4% at 90 days

Complications: ≤10% at 90 days

• Anastomotic leakage
• Bleeding requiring blood transfusion
• Pneumothorax
• DVT
• Pulmonary embolism
• Respiratory failure
• Cardiac arrest
• Myocardial infarction
• Heart failure
• Liver failure
• Multi organ failure
• Renal failure
• Sepsis and SIRS

Readmissions: ≤8% at 90 days

• Anaemia
• Bleeding
• Dehydration
• Erosion
• Food intolerance
• Neurological complication
• Intestinal obstruction
• Band related complications
• Malnutrition and vitamin deficiencies

Reoperations: ≤5% at 90 days

Programme Director:

The applicant/ bariatric surgeon would be the Programme Director.
A four-member Bariatric coordination committee would need to be constituted with the following members:

Bariatric surgeon,
Physician / Endocrinologist
Anesthetist
Nutritionist
Nursing Manager

The applicant holds interdisciplinary team meetings at least quarterly to ensure that decisions related to bariatric surgery are addressed in a comprehensive manner. The minutes of the meetings need to be recorded and will be checked by the assessor. The Director would be primarily responsible for coordinating the interdisciplinary services and guidelines for bariatric surgery.

Consultative Services:

This would comprise of

Full time with 24 hour coverage

• A Full time dedicated Anaesthesiologist team who supervise anaesthesia on all bariatric surgery patients.
• A fully equipped Intensive Care Unit with a full time Critical Care Team (CCM) who manage the patient in the immediate postoperative period and during any sudden emergency, respiratory or cardiac arrest through its acute response team.
• Endocrinologist / Diabetologist, or, at least one of which is available on-site at all times when patients are present, with an established protocol to follow for patients with metabolic syndromes

On-site within 30 minutes of request:

• Gastroentrologist capable of performing endoscopies to diagnose complications
• Interventional radiologist or other physician capable of performing percutaneous drainage of intra-abdominal abscess.
• Integrated Physician with critical care credentials to manage complications (Cardiologist or Pulmonologist)

The facility is also able to identify the following consultative staff:

• Psychiatrist/Mental health provider
• Infectious disease specialist
• Emergency department
• Physiotherapy and Occupational therapy
• Ambulance services
• Full fledged in-house laboratory / blood storage

Equipment And Instruments:

• Furniture in the OPD.
• Body Composition Analyzer in OPD.
• Wide wheelchairs to accommodate bariatric patients
• Blood pressure cuffs and Examination gowns.
• Bariatric Inpatient beds
• Floor-mounted or Floor-supported toilets.
• Availability of Crash Cart in the Recovery room and wards where the patients would be shifted in the postoperative period.
• Specific Operating room tables to accommodate Bariatric patients. Bariatric specific Surgical instruments.
• Presence of Fibrotic laryngoscope / Bronchoscope in OR for difficult airways.
• Radiologic capabilities like CT scan, Fluoroscopy / Dye study, etc.
• Personnel trained in the safe operation of the equipment and capable of moving patients without injury to the patient or themselves.

Surgeon Dedication And Qualified Call Coverage:

The applicant facility has policies and guidelines in place that require applicant / all eligible bariatric surgeons to have qualified call coverage, and the applicant surgeon certifies that each covering surgeon is capable of identifying and treating bariatric surgery complications.

The applicant surgeon spends a significant portion of his efforts in the field of bariatric surgery and completes continuing medical education. The applicant surgeon is a general/ gastrointestinal surgeon by the highest certifying authority, is a member of OSSI for at least 3 years. The applicant surgeon has privileges as both a bariatric and general surgeon at the applicant facility. The application facility should have a dedicated department of bariatric and metabolic surgery under which all the protocols, guidelines and SOP’s are functioning.

Clinical Pathways And Standardized Operating Procedures:

The applicant formally adopts and implements clinical pathways that facilitate the standardization of perioperative care for the relevant procedure:

• Preoperative multidisciplinary evaluation, education, preparation, admission workup/evaluation and informed consent of the bariatric surgery candidate.
• Anesthesia, including monitoring and airway management
• Perioperative care, including monitoring and airway management
• Deep vein thrombosis (DVT) prevention.
• Management protocols like Enhanced Recovery After Surgery (ERAS)
• Identification and evaluation of early warning signs of complications
• Preoperative, postoperative and long-term nutrition regimen.
• Pain management.
• Postoperative Follow up including entering data in the OSSI Registry.

Patient Education:

The applicant provides organized and supervised support groups for all patients who may undergo or have undergone bariatric surgery.

Continuing Medical Education:

The applicant / facility would be committed to spread the science of safe Bariatric surgery. At least two courses/ CME’S would be conducted every year by the facility to impart teaching and training of surgeons in the field of Bariatric and Metabolic surgery.

Onsite Inspection For Accreditation:

1. The application for the accreditation will be filled online through official OSSI website www.theossi.com. The application will be accompanied with an online payment to the OSSI account for a non-refundable amount of Rs 100,000/= (One lakh only). Subsequent to receiving the fees OSSI President will credential the application and if approved, appoint two assessors for an onsite inspection. The cost of travelling and local hospitality for the assessors will be taken care by OSSI. Subsequent to the inspection, if the facility is approved , the accreditation will be valid for a period of 3 years.

In case the assessors suggest certain changes/ modifications , the same would need to be completed in a period of one month by the applicant/facility and proof would need to be submitted to the assessors for the final report.

2. Facilities already approved by the SRC as Centre Of Excellence would be exempted from inspection and will be given the accreditation after applying online along with the payment of non-refundable fees of Rs 100,000/= (One lakh only). However, the application will still be credentialed by OSSI president before approving the COE for these centres.

3. Revalidation of the applicant/ facility will take place after three years. Revalidation non-refundable fees of Rs 100,000/=(One lakh only) is to be submitted with online payment to the 'OSSI' account.

An onsite inspection of the facility by a single assessor will be done. The cost of travelling and local hospitality for the assessor will be taken care by OSSI.

4. If the Programme Director leaves the facility, it would cease to exist as a "Centre Of Excellence". A fresh application with a new Programme Director would need to reapply and meet the desired criteria.

Certification

The certification would carry the:

• Seal of the Centre of Excellence.
• Name of the Facility.
• Name of the Programme Director.
• Duration of the certification.